The FDA has recently approved the use of potent opioid Dsuvia for the management of acute pain in adults. This news has created a major alarm in the medical community. Already, there is an ongoing opioid overdose epidemic, and there have been concerns regarding the over-prescription and overuse of narcotic analgesics. The FDA was asked to reject the approval of Dsuvia by the advisory committee, but the FDA failed to heed the advice.
Dsuvia (sufentanil) is a synthetic opioid that has been around since the 1980s. During those days, it was used as an epidural but was later taken off the market. The drug is 10 times more potent than fentanyl, which has recently been involved in countless drug overdoses.
Dr. Raeford Brown chairman of the FDA’s advisory committee wrote a memo indicating that Dsuvia has marked potential for diversion, and will most likely be involved in abuse and deaths within a few months after release.
Dr. Scott Gottlieb, the FDA commissioner, defended the agency’s decision to release the drug stating that Dsuvia will only be available as a prefilled single-dose applicator and is only permitted for use in healthcare institutions and in special circumstances where soldiers on the battlefield may not have access to intravenous painkillers. Dr. Gottlieb went on to state that Dsuvia has not been approved for home use and will not be available in retail pharmacies. The drug will only be administered by healthcare providers as a single dose applicator.
Dsuvia is set to hit the market early in 2019. Dr. Gottlieb has also stated that these measures will help prevent misuse and abuse of the drug. He also mentioned that the FDA has new powers that will enable it to determine how Dsuvia is being used in the medical community and if there are future concerns, the drug may be withdrawn.
Last year, the FDA requested the maker of Opana ER, another very potent opioid, to have the drug taken off the market because of concerns related to abuse.
The manufacturer of Dsuvia, AcelRx, has stated that they will diligently follow a safety and monitoring program to ensure that there is no abuse or diversion. The medical establishment has been greatly divided about the introduction of yet another opioid, in the face of an opioid epidemic that has already cost 40,000 lives just last year. Almost every state has cracked down on doctors with liberal opioid prescribing habits, and the DEA has closed down many pain clinics all over the nation. Only time will tell if Dsuvia is safe or not but for now the healthcare community is significantly shaken with this latest approval.